STANFORD UNIVERSITY MEDICAL CENTER 
STANFORD, CALIFORNIA 94305 
DEPARTMENT OF BIOCHEMISTRY 
Stanford University Schooi. of Medicine 
December 17, 1979 
Dr. Donald Fredrickson, Director 
National Institutes of Health 
Bethesda, MD 20205 
Dear Don, 
I am writing to express my approval of Section III-O, "Classi- 
fication of Experiments Using the E. coli K-12 Host-Vector Systems", 
of the proposed guidelines for recombinant DNA research published in 
the Federal Register of November 30, 1979. 
The biological data indicating that this reduction of containment 
is entirely consistent with public safety have been available for 
sometime. Indeed, Section III-O represents a minimal response to that 
data, which in my opinion is sufficient to eliminate these experiments 
from the guidelines altogether, as well as other equally innocous 
experiments. I do not, for example, think an argument for registra- 
tion and review of these experiments by the Institutional Biosafety 
Committee can be sustained on grounds of public safety, nor can I see 
why other E. coli K12 host-vector systems, such as those employing Ff 
bacteriophages, are not included within the Section III-O reduction. 
Even though it represents a minimal response, Section III-O is 
most certainly a good response. I hope that it is a harbinger of 
further reductional simplifications of the guidelines. These are 
sorely needed, both because many sections reflect imagined hazards for 
which there is no sustainable argument - rendering them arbitrary and 
capricious, and because the guidelines have attained a byzantine 
complexity that inhibits comprehension and induces ridicule. 
My last comments concern the decision-making process for changing 
the guidelines. I gather than in respect to Section III-O the 
Secretary of DHEW, Ms. Harris, is not content with the normal process 
by which changes in the guidelines have been Effected in the past, and 
has interfered with that process to the extent of instructing you to 
put this proposal out for an additional 30 days of public comment. I 
find this interference injudicious and misguided. 
The normal process is complex and slow in the extreme - primarily 
because it allows more than ample opportunity for public comment and 
argument, even for the most trivial changes in the guidelines. In 
this case, the subject was raised and published for public comment in 
the Federal Register on April 13, 1979 - more than eight months ago. 
Given that the question has been under almost constant public review 
in the United States and in many other lands, both prior and 
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